Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with Recalled by Terumo Cardiovascular Systems Corp Due to Incorrect customer notification label applied to the Tyvek...

Date: March 28, 2014
Company: Terumo Cardiovascular Systems Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corp directly.

Affected Products

Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431

Quantity: 37 units

Why Was This Recalled?

Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Terumo Cardiovascular Systems Corp

Terumo Cardiovascular Systems Corp has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report